Non-invasive device and method for treating gastro esophageal reflux disease (GERD) and the digestive system

ABSTRACT

A non-invasive method and device for treating gastroesophageal reflux disease (GERD) in a patient are disclosed. The method calls for positioning electrodes, and applying electrical symmetrical bursts. In particular, positioning step requires positioning a plurality of electrodes in electrical contact with the skin of a target region of the abdomen of the patient. The application step calls for applying a series of electrical symmetrical bursts to said electrodes. That application step generates contractions of abdominal muscles thereby generating movements of a digestive system of said patient wherein said movements are for causing the content of the esophagus to return to the stomach and to relieve GERD symptoms of said patient.

FIELD OF THE INVENTION

The present disclosure relates to medical devices in general, and tomedical devices related to digestive system and GERD in particular.

BACKGROUND OF THE INVENTION

Gastroesophageal reflux disease (GERD) is caused by stomach acid comingup from the stomach into the esophagus. The symptoms include abdominalpain, heart burn, asthma, mucosal damage and even cancer. GERD isusually caused by changes in the barrier between the stomach and theesophagus, including abnormal relaxation of the lower esophagealsphincter (LES) (which normally holds the top of the stomach closed),impaired expulsion of gastric reflux from the esophagus, or a hiatalhernia.

Treatment is typically via lifestyle changes and medications such asproton pump inhibitors (PPI), H2 receptor blockers or antacids.Medication therapy is effective up to 60% of the western worldpopulation. It is associated with various adverse effects, raisingconcern about the safety of its long-term use.

Surgical therapy (fundoplication) and endoscopic interventions providean alternative to patients who do not respond to medication therapy, orare reluctant to use such medications for long periods of time, but itis associated with adverse effects. Various endoscopic interventionmethods were developed in the last number of years, however, poorefficacy and complications have limited their use in clinical practice.The efficacy of all surgical interventions is decreasing in time.

U.S. Pat. No. 7,660,636 discloses an electrical stimulation device andmethod for the treatment of dysphagia. In a preferred embodiment, theelectrical stimulation device includes one or more channels ofelectrodes each of which includes a first electrode positioned inelectrical contact with tissue of a target region of a patient and asecond electrode positioned in electrical contact with tissue of aposterior neck region or a posterior thoracic region of the patient. Aseries of electrical pulses are then applied to the patient through theone or more channels of electrodes in accordance with a procedure fortreating dysphagia.

U.S. Pat. No. 5,716,385 an electronic pacemaker is used to counter-actcrural diaphragm relaxation thereby preventing and/or treatinggastroesophageal reflux. The pacemaker can be implantable, or beconnected to the skeletal muscles of the crural diaphragm through theskin. A sensor is used to identify spontaneous intermittent relaxationsof the diaphragm. During these spontaneous intermittent relaxations, oneor more electrodes are used to stimulate the skeletal muscles of thecrural diaphragm to cause contraction of the lower esophageal sphincter.

SUMMARY OF INVENTION

Embodiments of the present invention disclose a non-invasive device forfacilitating therapy of patient suffering from the gastrointestinalsystem diseases or symptoms, and in particular sufferingGastroesophageal reflux disease (GERD). The device is a noninvasivedevice that is positioned by the patient on the skin of the patientabdomen and electrically stimulates the abdomen muscles. This treatingresults in dynamic motions of the digestive system, which causes thetreatment of various digestive symptoms or diseases.

In one embodiment, the device causes an increase of the esophagusmotility and strengthens the esophageal sphincter, which releases orsuppresses the Gastroesophageal reflux symptoms.

In one other embodiment, the electrical stimulation directs the stomachcontents to creep up to the esophagus, causing unpleasant sensationleading to decrease the appetite. The unpleasant sensation occurs whendevice works both during eating and/or in between meals. The treatmentincreases the stomach pressure and facilitates the satiation feeling asobesity treatment.

In one other embodiment the electrical stimulation causes the stomachcontents to creep down to the duodenum and to empty the stomach. Thistreatment is effective in case of paralysis of the stomach.

In one other embodiment the electrical stimulation cause the transversescolon contents to creep down to the sigmoid colon as a treatment ofconstipation. In such a case, two channels stimulation may be used.

The device may be built from a sealed plastic case that contains anelectrical circuit and a battery/batteries pack in one embodiment, apair or more of electrodes coated with conductive adhesive (or hydrogel)or other any type of electrodes are attached to the case. In some otherembodiments, some or all of the electrodes are separated from the caseto be able to locate the electrodes in various locations of the patientabdomen. The device is integrated with a belt that the patient wears.The stimulation program begins when two or more electrodes are incontact with the skin. The user can control the device by keys on thedevice or by any remote control facilities.

The device is self-applied for daily use, typically after meal. In orderto determine the optimal application location on the patient body andfind the device optimal parameters (e.g. amplitude, frequency andburst/pulse sequence, etc.) an initial set up session may be required.This session can be done with a trained clinician or via printed orvideo user guide.

The stimulation pulses may be monophasic or asymmetrical or symmetricalbiphasic in typical rang with a specific time pattern or modulatedpattern wherein time pattern or modulated pattern are denoted as a burstand asymmetrical burst is denoted as a current wave form in which thetime of ramp up is different from the time of ramp down. Max Voltagerange is +300V (typically 200V), max current range is 150 mA (typical100 mA); pulse frequency range is 10 Hz-100 Hz (typical 20 Hz-4, burstfrequency 0.1-10 Hz (typical 0.25 Hz-4 Hz).

In some embodiments, the pulses are synchronized with the patient bodysignals. For example, the pulses may be synchronized with breathing,heart pulse, monotony movements, and body position. Synchronizing may bedone by a sensor that is included in the device. Examples of suchsensors are Accelerometer, Gyro, Magnetic Compass, Inclinometer andRespiratory Transducer based on a piezoelectric device (for sensing bodyposition, movements and breathing), ECG amplifiers and microphone (forsensing heart rate).

Breathing, body position and movements changes the stomach and esophaguspressure and position. The synchronization is required for generatingoptimal pulses only while the abdomen pressure is positive through theinspiration cycles.

One technical problem dealt with by the present disclosure is how toaffect motility of the esophagus and stomach system or/and the diaphragmof a patient in a non-invasive way.

One technical solution is to continuously electrically stimulating theabdomen muscles, with specific bursts wherein the frequency and thepower of stimulation may be controlled by the patient. The burst rapidramp up direction may be determined in accordance with the symptom. Forexample, in the case of Gastroesophageal reflux disease (GERD) aspecific current wave forms and treatment protocols cause the effect ofcreeping materials to the stomach direction for treating GERD patient.

One other technical solution is to create the dynamic motions by a beltthat contains a pulse motion mechanism. When the subject wears the beltthe mechanism is positioned onto a selected region or regions of thepatient abdomen. The mechanism extends and release reciprocally(alternatively inflates and deflates) causing the abdomen wall to followits movements. The mechanism is activated by a few optional electricalcurrent patterns that are generated by the control unit and synchronizedwith the patient body signals.

One technical problem dealt with by the present disclosure is how tocause movement of the content of digestive system of a patient in a noninvasive way.

One technical solution is to generate asymmetrical movements of thedigestive system (like the esophagus) by applying asymmetricalelectrical stimulation bursts onto the abdomen muscles, wherein thefrequency and the power of stimulation may be controlled by the patient.The asymmetrical bursts generate abdomen muscles asymmetricalcontractions. Those contractions generates forward and “fast back”displacement of the esophagus (via the stomach) causing the remainingmaterials creeping back to the stomach, like in “Vibration Conveyer”,wherein the ramp direction is determined in accordance with the desireddirection of the digestive system. For example, in the case ofGastroesophageal reflux disease (GERD) a fast ramp direction is upwardand the slow phase is downward, causing the content of the esophagusreturn to the stomach and release the GERD symptoms of the patient.

One other technical problem dealt with by the present disclosure is howto strengthen the esophageal sphincter

One other technical solution is electrically stimulating the abdominalmuscles. For every burst of stimulation the pressure in the stomachincreases causing the esophageal sphincter muscle to contract and toprevent the stomach content entering to the esophagus, numerous timesevery day. The numerous contractions of the sphincter muscle causethickening and strengthening of the sphincter which prevent the refluxsyndrome in long term.

One other technical problem is how to optimize the stimulation effect. Aburst that acts during the abdomen negative pressure cycles it noteffective though a burst that acts during the abdomen positive pressurecycles it effective.

One other technical solution is synchronizing the pulses timing with thepatient body signals. Breathing, body position and movements changes thestomach and esophagus pressure and position. The synchronization isrequired for generating optimal pulses only while the abdomen pressureis positive through the inspiration cycles. In another embodiment thedevice synchronizes the pulses generation with heart beat rate measuredby ECG (electrocardiogram) sensor. Pulses are generated during theperiods of positive values. In another embodiment body position isperformed by Gyro and/or accelerometer sensors.

One exemplary embodiment of the disclosed subject matter is a method fortreating gastroesophageal reflux disease (GERD) in a patient. The methodcomprising: positioning a plurality of electrodes, in electrical contactwith the skin of a target region of the patient abdomen; and applying aseries of electrical bursts to the electrodes wherein the electricalbursts are adapted for electrically stimulating the abdomen muscles ofthe patient in the target region; thereby causing the esophagealcontents to creep down to the stomach.

According to some embodiments the method further comprising applying aseries of electrical asymmetric bursts to thereby generatingasymmetrical contractions of the muscles; wherein a direction of a fastphase of the bursts being upward and a direction of a slow phase of thebursts being downward; thereby generating movements of a digestivesystem of the patient; wherein the movements being for causing thecontent of the esophagus to return to the stomach and to release theGERD symptoms of the patient. According to some embodiments the methodfurther comprising synchronizing the pulses with the patient bodysignals. According to some embodiments the body signals comprise onemember of a group consisting of breathing, heart pulse, monotonymovements and body position.

One other exemplary embodiment of the disclosed subject matter is anon-invasive device for treating the digestive system symptoms of apatient; the device comprises: a plurality of electrodes adapted to beplaced in electrical contact with the skin of the abdomen; a pulsegenerator 107 for providing asymmetric bursts electrical stimulation tothe electrodes; wherein the asymmetric bursts being for stimulating theabdomen muscles for a moving the digestive system; wherein the movingbeing for treating a digestive symptom or a diseases; a control unit 103for controlling the pulse generator 107 wherein maximum voltage range ofthe pulse being +300V, maximum current range being 150 mA; pulsefrequency range being 10 Hz-100 Hz and burst frequency being 0.1-10 Hz asensor connectable to the control unit adapted for sensing body-signalsfrom the patient; wherein the control unit is further adapted forsynchronizing the pulse generator 107 in accordance with thebody-signals to thereby improving the effect of the electricalstimulation.

According to some embodiments the device digestive system symptoms beingone member of a group consisting of reflux, obesity and constipation.According to some embodiments the pulse generator 107 is configured todetermine the pulse ramp up direction in accordance with the desireddirection. According to some embodiments the sensor being one member ofa group consisting of a Piezoelectric Respiratory Belt Transducer forsensing breathing rate, an ECG for sensing heartbeat, a Gyro andaccelerometer for sensing body movements.

One other exemplary embodiment of the disclosed subject matteranon-invasive device for treating gastroesophageal reflux disease of apatient; the device comprises: a plurality of electrodes adapted to beplaced in electrical contact with the skin of the abdomen; a pulsegenerator 107 for providing asymmetric electrical stimulation bursts tothe electrodes; wherein the asymmetric electrical stimulation burstsbeing for generating asymmetrical contractions of the muscles; wherein adirection of a fast phase of the bursts being upward and a direction ofa slow phase of the burst being downward; thereby generating movementsof a digestive system of the patient; wherein the movements being forcausing the content of the esophagus to return to the stomach and torelease the GRED symptoms of the patient; a control unit for controllingthe pulse generator 107 and a sensor adapted for sensing breathingsignals from the patient; wherein the control unit is further adaptedfor synchronizing the pulse generator 107 in accordance with thebreathing signals to thereby generating pulses only when the abdomenpressure is positive. According to some embodiments the pulse generator107 is further configured for providing symmetric electrical stimulationbursts.

One other exemplary embodiment of the disclosed subject matter a devicefor treating gastroesophageal reflux disease (GERD) of a patient; thedevice comprises: a plurality of electrodes adapted to be placed inelectrical contact with the skin of the abdomen; a pulse generator 107for providing electrical stimulation signals to the electrodes; whereinthe electrical stimulation bursts being for directing the stomachcontents to creep up to the esophagus, to thereby causing unpleasantsensation leading to decrease the appetite for treating obesity orwherein the electrical stimulation bursts being for causing the stomachcontents to creep down to the duodenum and to empty the stomach fortreating paralysis of the stomach or wherein the electrical stimulationbursts being for causing the transverses colon contents to creep down tothe sigmoid colon to thereby treating constipation; and a control unit103 for controlling the pulse generator 107.

THE BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

The present disclosed subject matter will be understood and appreciatedmore fully from the following detailed description taken in conjunctionwith the drawings in which corresponding or like numerals or charactersindicate corresponding or like components. Unless indicated otherwise,the drawings provide exemplary embodiments or aspects of the disclosureand do not limit the scope of the disclosure. In the drawings:

FIGS. 1A and 1B illustrate a device for treating the digestive system inaccordance with some embodiments of the disclosed subject matter;

FIG. 2 illustrates an example of the asymmetrical burst stimulationmonophasicpulses or half wave in case of biphasic pulses, in accordancewith some embodiments of the disclosed subject matter;

FIG. 3 is an illustration of user wearing the device on the abdomen, inaccordance with some embodiments of the disclosed subject matter;

FIG. 4 is an illustration of typical data that is generated by aPiezoelectric Respiratory Belt Transducer, in accordance with someembodiments of the disclosed subject matter;

FIG. 5 is an illustration of a subject wearing, on the abdomen, a devicewith a pulse motion mechanism, in accordance with some embodiments ofthe disclosed subject matter;

FIG. 6 is a top view illustration of a device with a pulse motionmechanism, in accordance with some embodiments of the disclosed subjectmatter; and

FIG. 7A to 7C illustrate a force and displacement pulse pattern of thedevice, in accordance with some embodiments of the disclosed subjectmatter.

DETAILED DESCRIPTION OF THE INVENTION

FIGS. 1a and 1b illustrate a device for treating the digestive, inaccordance with some embodiments of the disclosed subject matter.

FIG. 1a is a top view of the device in accordance with some embodimentsof the disclosed subject matter. The device (not shown in this figure)can be worn on the user body via adjustable belt and or pressuresensitive adhesive (PSA). The device (not shown in this figure)generates electrical pulses that are delivered to the user abdomenmuscles via two or more electrodes. The device (not shown in thisfigure) includes a control unit 103, a control unit case 106, anadjustable belt 104 and a plurality of electrodes 101 and 102.

The control unit 103 includes the electric circuit (printed board) PCBand a battery or multiple batteries pack (not shown in this figure). Thecontrol unit 103 includes two or more keys or knobs 105 for turningon/off, selecting the required operation protocol and pulse parameters,and two (or more) LEDs (not shown) for status indication. The controlunit 103 is explained in greater details in FIG. 1b . The adjustablebelt (104) is adapted ensures comfortable and proper attachment of thedevice (not shown in this figure) to the user body and allows dailyactivities.

The control unit case 106 may be constructed to be adequately flexiblein order to allow good fit with the user body.

The electrodes 101 and 102 are each adapted to be positioned inelectrical conduct with the skin of selected regions of a patientabdomen. The electrodes 101 and 102 are replaceable and disposable; theyare supplied to the user packed in a sealed watertight package. Theelectrode structure contains multiple layers that may include asubstrate liner; polymer film (e.g. polyester) or foam (e.g.polyurethane) or nonwoven (e.g. polypropylene fibers) coated withconductive layer (e.g. a bland of silver silver-chloride or graphite ormetal) and an aqueous conductive adhesive (e.g. conductive hydrogel orviscose layer with water). The electrodes are attached to the controlunit side wall or integrated into the adjustable belt 104, and connectedto the control unit 103 via special conductive wires 110. A siliconizedfilm (release liner) protects the adhesive/hydrogel and is removedbefore use.

The electrodes 101 and 102 may be integrated (as shown this figure) orseparated (as shown FIG. 3) from the device (not shown in the figure)and can be located in various locations of the user abdomen.

In order to allow daily operation through clothes there is an option toremotely control the device (not shown in this figure) by using awire/wireless remote control unite or a special unit with magnet thatmagnetically operates the switches of the device.

FIG. 1b illustrates the control unit in accordance with some embodimentsof the disclosed subject matter. The control unit 103 includes controlkeys 105, a case 106 and printed circuit board (PCB) 108. The PCB 108includes microcontroller, digital circuits, memory, communication, highvoltage circuits, analog circuits, high voltages switches and bridges,protection circuits (not shown) and the pulse generator 107. The controlunit 103 is connected to the electrodes (not shown) with the electrodesconductive wires 110. The control unit 103 is in electrical contact withthe sensors (not shown) via conductive wire 111. The control unit may becontrolled by any remote control device with any type of communication.

FIG. 2 illustrates an example of the monophasic asymmetrical burststimulation pulses 200 and the biphasic stimulation pulses 210, inaccordance with some embodiments of the disclosed subject matter. Inanother embodiment, more types of asymmetrical burst and pulses may beused for example: skew nonlinear curves, asymmetrical stairs pulses.

FIG. 3 is an illustration of user 300 wearing the device 100 on theabdomen, in accordance with some embodiments of the disclosed subjectmatter. The adjustable belt 104 is worn on the user 300. The adjustablebelt 104 includes a sensor 109. The sensor 109 is connected to thecontrol unit 103 via conductive wire (multiple wires cable) 111. Theelectrodes 401 and 402 are connected to the device 100 via conductivewires 110. The second electrode 402 or both electrodes 401 and 402 maybe integrated (as shown in FIG. 1) or separated (as shown in thisfigure) from the device 100 and can be located in various locations ofthe user abdomen. This structure allows deeper penetration of the pulsecurrent and may be required primarily by obese users with thick layer offate that may prevent the current to reach the inner abdomen muscles.

FIG. 4 is an illustration of typical data that is generated by aPiezoelectric Respiratory Belt Transducer, in accordance with someembodiments of the disclosed subject matter. The figure illustrates thechange in voltage as a result of a change in thoracic or abdominalcircumference due to respiration. By measuring the voltage change thedevice synchronizes the pulses generation with breathing rate. Pulsesare generated during the periods of positive values.

FIG. 5 is an illustration of a subject wearing, on the abdomen, a devicewith a pulse motion mechanism, in accordance with some embodiments ofthe disclosed subject matter. According to some embodiments the dynamicmotions of the abdomen are created by a pulse motion mechanism 202 whichis mounted on a belt 201 that is worn on the subject 200. When thesubject 200 wears the belt, the mechanism is positioned onto a selectedregion or regions of the patient abdomen. The mechanism 202 extends andreleases sequentially (alternatively inflates and deflates) causing theabdomen wall to follow its movements. The mechanism 202 is activated bya suitable electrical current pattern (to create the required motion)that is generated by the control unit 203. The mechanism 202 may besynchronized with the patient body signals.

FIG. 6 is a top view illustration of a device with a pulse motionmechanism, in accordance with some embodiments of the disclosed subjectmatter. The pulse motion mechanism 202 may include, for example, anelectrical linear actuator or a Rotary actuator with an eccentric arm,both can drive a piston 204. The pulse motion mechanism 202 may alsoinclude an air bag (204). The piston 204 expands and releases insequence. The air bag 204 sequentially inflates and deflates and iscoupled with an electrical air pump and an air valve. The power may besupplied by a battery that is mounted in the control unit (not shown inthe figure). Arrow 205 shows the direction of the movement of the pistonor an air bag (204).

FIG. 7 illustrates force and displacement pulse patterns of the devicewith a pulse motion mechanism, in accordance with some embodiments ofthe disclosed subject matter. The resulting force and displacement pulsepattern includes sequential saw teeth pattern 701, asymmetrictrapezoidal pattern 702 and skewed sinusoidal pattern 703. It should benoted that the pattern may also include symmetrical rectangle pattern orsymmetrical sinusoidal pattern (not shown in the figure).

We claim:
 1. A non-invasive method for treating gastroesophageal refluxdisease (GERD) in a patient, the method comprising: positioning aplurality of electrodes in electrical contact with the skin of a targetregion of the abdomen of the patient; and applying a series ofelectrical symmetrical bursts to said electrodes to generatecontractions of abdominal muscles thereby generating movements of adigestive system of said patient wherein said movements are for causingthe content of the esophagus to return to the stomach and to relieveGERD symptoms of said patient.
 2. The method according to claim 1,further comprising synchronizing said pulses with one or more bodysignals of the patient, wherein said one or more body signals areselected from the group consisting of: breathing, heart pulse, monotonymovements and body position.
 3. The method according to claim 2, whereinsaid symmetrical bursts are modulated biphasic symmetrical pulses.
 4. Anon-invasive device for treating the digestive system symptoms of apatient, the device comprising: a plurality of electrodes in electricalcontact with the skin of a target region of the abdomen of the patient;a pulse generator for providing symmetrical modulated bursts of pulsesto said electrodes, wherein said modulated symmetrical burst of pulsesare for stimulating the abdomen muscles and for moving the digestivesystem, wherein said moving being for treating a digestive symptom or adisease; a control unit for controlling said pulse generator, wherein amaximum voltage range of said pulses is +300V, a maximum current rangeis 150 mA, a pulse frequency range is 10 Hz-100 Hz, and a burstfrequency range is 0.1-10 Hz; and a sensor connectable to said controlunit, wherein said sensor is adapted for sensing one or more bodysignals of the patient wherein said one or more body signals areselected from a group consisting of: breathing, heart pulse, monotonymovements and body position, wherein said control unit is furtheradapted for synchronizing said pulse generator in accordance with saidone of more body signals to improve effectiveness of said electricalstimulation.
 5. The device according to claim 4, wherein saidsymmetrical bursts are modulated biphasic symmetrical pulses.
 6. Thedevice according to claim 4, wherein said digestive system symptom orsaid disease are selected from the group consisting of gastroesophagealreflux disease (GERD), Gastroparesis and Constipation.
 7. The deviceaccording to claim 4, wherein said sensor is selected from at least oneof a piezoelectric respiratory belt transducer for sensing breathingrate, an ECG for sensing heartbeat, an accelerometer and a gyro forsensing body movements.
 8. A non-invasive device for treating digestivesystem of a patient, the device comprising: a plurality of electrodesadapted to be placed in electrical contact with the skin of a targetregion of the abdomen of said patient; a pulse generator configured forproviding symmetric electrical stimulation bursts to said electrodes togenerate symmetrical contractions of abdominal muscles of said abdomen;thereby generating movements of a digestive system of said patientwherein said movements are for causing content of the esophagus toreturn to the stomach and to relieve one member selected from a groupconsisting of gastroesophageal reflux (GERD) symptoms, Gastroparesis andConstipation of said patient.
 9. The device of claim 8 furthercomprising a control unit configured for controlling said pulsegenerator and a sensor adapted for sensing breathing signals from saidpatient; wherein said control unit is further adapted for synchronizingsaid pulse generator in accordance with said breathing signals togenerate pulses only when the abdomen pressure is positive.
 10. Anon-invasive device for treating gastroesophageal reflux disease (GERD)in a patient, the device comprising: a plurality of electrodes adaptedto be placed in electrical contact with the skin of a target region ofthe abdomen of the patient; and a pulse generator configured forproviding a series of electrical symmetrical bursts to said electrodesto generate contractions of abdominal muscles thereby generatingmovements of a digestive system of said patient wherein said movementsare for causing the content of the esophagus to return to the stomachand to relieve GERD symptoms of said patient.